Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986256 in Healthy Male Participants

Pharmacokinetics and Metabolism of a Single Dose of [14C] BMS-986256 in Healthy Male Participants

The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986856 in healthy males.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: BMS-986256; Drug: Milk of magnesia

Detailed Description

Recruitment temporarily on hold due to COVID-19.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance - Clinical Pharmacology Services - Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Healthy participants, as determined by no clinically significant deviations from normal in medical history, physical examination abnormalities that would compromise the ability to participate, complete, and/or interpret the results of the study, 12-lead electrocardiograms (ECGs), vital signs, and clinical laboratory results.
• Males must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion Criteria:

• Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study
• History of any significant drug and/or food allergies

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-986256	Drug: BMS-986256; Specified dose on specified days; Drug: Milk of magnesia; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax) of [14C] BMS-986256	Up to 49 days
Time to attain maximum observed plasma concentration (Tmax) of [14C] BMS-986256	Up to 49 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)) of [14C] BMS-986256	Up to 49 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events (AEs)	Up to 49 days
Incidence of Serious Adverse Events (SAEs)	Up to 49 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests	Up to 49 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests	Up to 49 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests	Up to 49 days
Incidence of clinically significant changes in vital signs: Blood pressure	Up to 49 days
Incidence of clinically significant changes in vital signs: Heart rate	Up to 49 days
Incidence of clinically significant changes in vital signs: Respiratory rate	Up to 49 days
Incidence of clinically significant changes in vital signs: Body temperature	Up to 49 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters	Up to 49 days
Incidence of clinically significant changes in physical examination findings	Up to 49 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2020
• Primary Completion (Actual): March 30, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 12, 2020
• First Posted (Actual): February 13, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Magnesium Hydroxide; Magnesium Oxide
• Other Study ID Numbers: IM026-023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No